Spots Global Cancer Trial Database for A Study of PNT2258 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of PNT2258 in Patients With Advanced Solid Tumors
Official Title: A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors
Study ID: NCT01191775
Interventions
Study Description
Brief Summary: This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.
Detailed Description: This study is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). At first, patients will be treated in single patient cohorts following an accelerated titration design and evaluated for toxicities. After the accelerated portion ends, patients will be treated in cohorts of at least 3 patients at each dose level and evaluated for treatment-related toxicities.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Contact Details
Name: Anthony W Tolcher, MD, FRCP(C)
Affiliation: South Texas Accelerated Research Therapeutics (START)
Role: PRINCIPAL_INVESTIGATOR
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